Acetaminophen by CHAIN DRUG MARKETING ASSOCIATION INC. / Seaway Pharma Inc. ACETAMINOPHEN syrup

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by CHAIN DRUG MARKETING ASSOCIATION INC., Seaway Pharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient                         Purpose

(In each 15 mL)

in Acetaminophen 500 mg............. Pain reliever/fever reducer

PURPOSE

• Pain Reliever
• Fever Reducer

Uses

• temporarily relieves minor aches and pains due to:
  • the common cold
  • headache
  • backache
  • minor pain of arthritis
  • toothache
  • muscular aches
  • premenstrual and menstrual cramps
  • temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 4,000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening
• blisters
• rash

if skin reaction occurs, stop use and seek medical help right away.

Do not use

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• if your child is allergic to acetaminophen or any of the inactive ingredients in this product.

Ask a doctor before use if you have 

liver disease.

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

STOP USE

Stop use and ask a doctor if

• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• new sympthoms occur
• redness or swelling is present

These could be signs of a serious condition.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OVERDOSAGE

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away.

Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• do not take more than directed (see Overdose warning)
• do not take more than 4 doses in any 24-hour period
• measure only with dosing cup provided. Do not use any other dosing device.
• mL=milliliter
• keep dosing cup with product
• adults and children 12 years and over
• 30 mL every 6 hours while symptoms last
• do not take more than 10 days unless directed by a doctor
• children under 12 years: do not use

Other information

• each 15 mL contains: sodium 10 mg
• store between 20-25°C (68-77°F). Do not refrigerate.
• protect from light.

Questions or comments
1-800-935-2362 (Mon-Fri 9am-5pm EST)

Inactive ingredients

citric acid, D&C red #33, FD&C red #40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium,
sodium benzoate, sorbitol

SPL UNCLASSIFIED SECTION

• TAMPER EVIDENT: Do not use if the safety seal around or under the cap is broken or missing
• *Compare to Active Ingredient in Tylenol® Extra Strength*
• *This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Extra Strength Tylenol®

Distributed by C.D.M.A, Inc.©
43157 W 9 Mile Rd
Novi, MI 48375
www.qualitychoice.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-809
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-809-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	07/01/2023

Labeler - CHAIN DRUG MARKETING ASSOCIATION INC. (011920774)

Registrant - Seaway Pharma Inc. (117218785)

Establishment
Name	Address	ID/FEI	Business Operations
Seaway Pharma Inc.		117218785	manufacture(63868-809)